Randomized Controlled Study on T-PEP Versus IPV Method for Lower Respiratory Airways Clearance in Tetraplegic Tracheotomized Spinal Cord Injured Patients (T-PEP)

Randomized Controlled Study on the Evaluation of the T-PEP Method Based on Positive Expiratory Pressure Versus Intrapulmonary Percussive Ventilation for Lower Respiratory Airways Clearance in Sub-acute, Tetraplegic, Tracheotomized Spinal Cord Injured Patients

In tetraplegic patients with complete cervical spinal cord injury, respiratory complications are very frequent, especially in the sub-acute phase: the lungs often become obstructed due to the accumulation of secretions and the contemporary inefficiency of the cough mechanism. The present pilot study aims, in the context of a rehabilitative Critical Care Unit, at evaluating a not yet published method, called "T-PEP" and based on the principle of Positive Expiratory Pressure, applicable to tracheotomised and mechanically ventilated patients. This method, conceptually simple and low cost, is compared with a known method based on the principle of Percussive Intrapulmonary Ventilation (IPV). Safety and efficacy issues are covered.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Cord Injury Cervical
• Intervention / Treatment: Procedure: T-PEP; Procedure: IPV

Detailed Description

Respiratory complications are very frequent, especially in the sub-acute phase following a spinal cord injury and must be treated to avoid even very serious outcomes. In the patient with a complete cervical spinal cord injury (and therefore tetraplegic, from a motor perspective), the lungs often become obstructed due to the accumulation of secretions and the contemporary inefficiency of the physiological mechanism of the cough. Various methods for bronchial clearance are known, but when the patient is tracheotomized and the secretions accumulate in the deepest part of the lung, nowadays the only described method available to mobilize such secretions and allow more efficient respiratory exchanges is based on the principle of Percussive Intrapulmonary Ventilation (IPV). It requires a special device, equipped with a pneumatic air generator, connected to the tracheal cannula. Such treatment needs the assistance of highly trained and expert operators, moreover IPV is a quite complex and expensive technique which has to be applied in a prudential manner in such tetraplegic patients, especially because they show significant hemodynamic instability in the acute/sub-acute phase after the spinal cord lesion.

The principle of Positive Expiratory Pressure (PEP) is already known for its efficacy in the secretions' clearance of the lower respiratory airways in other pathological conditions. However, in its classic modalities, it requires the preservation of the functionality of the respiratory muscles. To circumvent this limit in tetraplegic and tracheotomized patients, a respiratory physiotherapeutic procedure called "T-PEP" has been developed at the Montecatone Rehabilitation Institute. Such method is conceptually simple and low cost, it requires the manual assistance of a trained physiotherapist and the use of some components of common use in the clinical practice of Critical Care Units.

The present pilot randomized controlled trial aims at comparing the T-PEP and IPV methods, assigned to 2 parallel arms (1:1 allocation ratio), in the context of the Critical Care Unit of the Montecatone Rehabilitation Institute hospital, in sub-acute, tetraplegic, tracheotomized, mechanically ventilated, spinal cord injured patients. The trial covers safety and efficacy issues; cognitive performances are also addressed.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Imola, BO, Italy, 40026
      • Montecatone Rehabilitation Institute S.p.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• spinal cord injury due to traumatic or non-traumatic etiology;
• neurological level from C4 to C7 (included)
• complete spinal cord injury, classifiable as "A" grade according to the Asia Impairment Scale (AIS);
• distance from the spinal cord injury event from 1 to 5 weeks;
• first admission to Montecatone R.I. (in particular to the Critical Care Unit);
• patients with middle-basal hypoventilation;
• patients in partial or continuous mechanical ventilation;
• patients with tracheotomy;
• patients capable of giving meaningful consent;
• collaborating patients.

Exclusion Criteria:

• thoracic trauma with non-drained thoracic fractures and / or pneumothorax and / or hemorrhage;
• pleural effusion;
• significant hemodynamic instability needing amines administration and / or Shock Index > 1.5;
• patients with tracheoesophageal fistulae;
• patients with severe acquired brain injury;
• patients with ongoing sepsis;
• patients with ongoing pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: T-PEP; Each T-PEP session includes 10 inspiratory/expiratory cycles, repeated 3 times and interspersed by a pause of about 3 minutes. Each session will be immediately followed by bronchoaspiration and/or Mechanical Insufflation-Exsufflation (MI-E). Sessions will take place at least twice a day for a number of days until the attainment of an effective pulmonary ventilation (as detected by thoracic auscultation), then continued for a further 3 days (at least 2 times a day) for the outcome stabilization, as confirmed also by arterial-blood gas test (ABG), spirometry, chest X-ray and chest ultrasound. T-PEP sessions will take place at least 1 hour after meals or nutrition via nasogastric tube. Tracheal cannula will be kept constantly cuffed during the sessions. Ipratropium Bromide treatment will be on place from study entry until at least 4 weeks after the attainment of a stabilized effective pulmonary ventilation.	Procedure: T-PEP; First of all, a corrugated tube for ventilation is assembled: in one end with an antibacterial filter for ventilation and then an inflation system (like Auxiliary Manual Breathing Unit - AMBU); in the other end with a connector and then a one-way PEP Valve. The latter holds a junction for the tracheal cannula and a pressure gauge. A Venturi Resistor is placed in the expiratory part of the PEP Valve. After connection to the tracheal cannula, the disostructive maneuver is manually executed by a respiratory physiotherapist.
ACTIVE_COMPARATOR: IPV; Each IPV session includes 3 treatment cycles, interspersed with a pause, consisting of a first high-frequency steps, lasting about 5 minutes, immediately followed by a second low-frequency step lasting approximately one minute. Each session will be immediately followed by bronchoaspiration and/or Mechanical Insufflation-Exsufflation (MI-E). Sessions will take place at least twice a day for a number of days until the attainment of an effective pulmonary ventilation (by thoracic auscultation), then continued for a further 3 days (at least 2 times a day) for outcome stabilization, as confirmed by ABG test, spirometry, chest X-ray and chest ultrasound. IPV sessions will take place at least 1 hour after meals or nutrition via nasogastric tube. Tracheal cannula will be kept constantly cuffed during the sessions. Ipratropium Bromide treatment will be on place from study entry until at least 4 weeks, after the attainment of a stabilized effective pulmonary ventilation.	Procedure: IPV; IPV is delivered via a commercial device that can be set by frequency, duration of inspiratory time, inspiratory-expiratory ratio and positive end-expiratory pressure, based on patients characteristics and clinical needs. It is connected to the patient's tracheal cannula via a Mount catheter. The air supplied is sterile, due to the presence of an antibacterial filter present in the device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Incidence of adverse events in the treatment period and during the subsequent follow-up, directly correlated with the lower airways cleaning treatments under investigation	Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) until the following 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time needed for attainment of a stabilized effective pulmonary ventilation	Number of days needed to attain the stabilization of an effective pulmonary ventilation, as confirmed simultaneously by all the following examinations: chest auscultation, ABG (for respiratory exchanges efficiency), spirometry (in particular: Forced Expiratory Flow 75% [FEF 75], for pulmonary patency), chest X-ray and chest ultrasound.	Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average)
Recurrence of lower airways obstruction	Incidence of recurrence of lower airways obstructions requiring retreatment with the lower airways treatments under investigation, in the study period following the attainment of stabilized effective pulmonary ventilation	From the attainment of stabilized effective pulmonary ventilation until 3 months later
Incidence of infections of lower respiratory airways	Incidence of acute infections of the lower respiratory airways, throughout the study period.	Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) and through the following 3 months
Incidence of sepsis	Incidence of sepsis related to acute infections of the lower respiratory airways, throughout the study period	Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) and through the following 3 months
Time needed for weaning from mechanical ventilation, from its start	Number of days needed to wean from mechanical ventilation, starting from the mechanical ventilation starting date (also if previously occurred in a sending hospital)	From mechanical ventilation start date until mechanical ventilation end date (up to 1 year)
Time needed for weaning from mechanical ventilation, from hospital admission	Number of days needed to wean from mechanical ventilation, starting from the date of admission to the Montecatone R.I. hospital	From admission date to Montecatone R.I. until mechanical ventilation end date (up to 1 year)
Evaluation of cognitive performance: attention and memory - 1	Neuropsychological test: Preliminary Neuropsychological Battery	Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: attention and memory - 2	Neuropsychological test: Verbal Span	Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: attention and memory - 3	Neuropsychological test: Immediate Visual Memory	Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: attention and memory - 4	Neuropsychological test: Digit Symbol Substitution test	Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: logical and executive functions - 1	Neuropsychological test: Verbal Fluency	Day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the day of attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: logical and executive functions - 2	Neuropsychological test: Progressive Matrices	Day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the day of attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: logical and executive functions - 3	Neuropsychological test: Verbal Analogies	Day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the day of attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: social cognition	Neuropsychological test: Eyes Test	3 months after the day of attainment of stabilized effective pulmonary ventilation
Costs of the T-PEP and IPV treatments - 1	Average costs of equipments used in the overall number of sessions with T-PEP or IPV treatments, needed to attain stabilized effective pulmonary ventilation	Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average)
Costs of the T-PEP and IPV treatments - 2	Average costs of consumables used in the overall number of sessions with T-PEP or IPV treatments, needed to attain stabilized effective pulmonary ventilation	Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average)

Collaborators and Investigators

• Sponsor: Montecatone Rehabilitation Institute S.p.A.
• Investigators: Principal Investigator: Carlotta Stopazzoni, MD, Montecatone Rehanilitation Institute SpA

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (ACTUAL): October 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Positive Expiratory Pressure; Mechanical ventilation; Tetraplegia; Tracheotomy; Intrapulmonary Percussive Ventilation; Respiratory physiotherapy; Lower respiratory airways clearance; Deep lung clearance; Secretions overproduction; Critical Care Unit
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: CE-378/2018/SPER/AUSLIM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No